Subject Matter Expert - Pharmacovigilance

Job Overview

We are looking to hire a Pharmacovigilance Subject Matter Expert with 2 to 4 years of experience. The successful candidate should have a robust background in Pharmaceutical Research & Development and a passion for pharmacovigilance data management and case evaluation. This role is a hybrid opportunity working onsite that involves ensuring drug safety and regulatory compliance within a dynamic setting.

Key Responsibilities

• Analyze pharmacovigilance data comprehensively to meet regulatory guidelines and improve medication safety.
• Work closely with various departments to execute and support pharmacovigilance strategies effectively.
• Provide expert advice on case processing procedures to ensure precise and prompt adverse event reporting.
• Leverage Pharma Research & Development expertise to enhance and innovate pharmacovigilance workflows.
• Oversee performance of pharmacovigilance systems, recommending enhancements when necessary.
• Document pharmacovigilance activities and findings thoroughly and accurately.
• Support preparation of regulatory dossiers and safety documentation ensuring global compliance.
• Stay updated on pharmacovigilance developments and best practices through continual learning.
• Contribute to staff training and development to strengthen team capabilities and effectiveness.
• Ensure integrity and precision of pharmacovigilance data to uphold high standards.
• Participate in audits and regulatory inspections demonstrating compliance and system robustness.
• Promote a culture prioritizing safety and vigilance to protect public health interests.
• Help achieve organizational goals by ensuring the safe use of pharmaceutical products.

Required Qualifications and Skills

• Strong pharmaceutical research and development foundation essential for pharmacovigilance program leadership.
• Proficiency in pharmacovigilance data management and case processing to improve safety evaluations.
• Excellent analytical abilities for interpreting complex pharmacovigilance data and generating actionable insights.
• Knowledge and experience with regulatory compliance related to international pharmacovigilance standards.
• Good communication skills to effectively collaborate with multidisciplinary teams and stakeholders.
• A proactive, problem-solving mindset that ensures prompt resolution of pharmacovigilance challenges.

Certification

Possession of a Certified Pharmacovigilance Professional (CPP) credential or an equivalent certification is preferred.